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IVDR-00793
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Coombscell-E® Control Cells
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Bio-Rad Laboratories (Singapore) Pte. Ltd. 3A International Business Park #11-10/16, ICON@IBP Tower B, Singapore 6009935 Mfd By: Bio-Rad Medical Diagnostics GmbH - Industriestr. 1 63303
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Singapore
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30 January 2024
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30 January 2025
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IVDR-00794
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I-Stat Total ß-hCG Cartridge
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Abbott Point of Care Inc. 400 College Road East Princeton NJ USA Mfd By: Abbott Point of Care Inc. - 100 and 200 Abbott Park, IL, USA
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USA
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08 February 2024
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08 February 2025
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IVDR-00795
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TRUST CLEAR CHECK MID-STREAM WAND TYPE PREGNANCY TEST
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Japan Long-Tei (China) Co., Ltd. 245, Jingliu Road, Jinan City, China Mfd By: Qingdao AIBO Diagnostic Co., Ltd. - No. 2 Wanmufangsi Raod, Jinkou, Jimo, 266200 Qingdao, People's Republic of China
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China
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08 February 2024
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08 February 2025
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| View |
IVDR-00796
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Vidas HCG
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Biomerieux SA 376 Chemin de l'Orme, 69280 Marcy l'Etoile, France
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France
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08 February 2024
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08 February 2025
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| View |
IVDR-00797
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Syphicheck WB Device Rapid Test for Syphilis Serum/Whole Blood Modified TPHA
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Tulip Diagnostics (P) Ltd and Coral Clinic Systems ( A Division of Tulip Diagnostics (P) Ltd.) Mfd By: Zephyr Biomedical - A Division of Tulip Diagnostics (P) Ltd. - Gitanjali - Tulip Block, Dr. Antonio Do Rego Bagh, Alto Santacruz, Bambolim Complex, Goa - India
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India
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08 February 2024
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08 February 2025
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| View |
IVDR-00798
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DISTINCT EARLY DETECTION PREGNANCY TEST MIDSTREAM
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Acon Laboratories, Inc. 5850 Oberlin Drive, #340 San Diego, CA 92121 USA Mfd By: Acon Biotech (Hangzhou) Co., Ltd. - no. 1 210 Zhenzhong Road, West Lake District 310030 Hangzhou, People's Republic of China
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USA
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08 February 2024
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08 February 2025
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| View |
IVDR-00805
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HIV Calibrators
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building Keji 12th Road South Hightech Industrial Park Nanshan 518057 Shenzhen PRC
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China
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06 March 2024
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06 March 2025
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| View |
IVDR-00806
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HIV Ag/Ab Negative Control
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building Keji 12th Road South Hightech Industrial Park Nanshan 518057 Shenzhen PRC
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China
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06 March 2024
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06 March 2025
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| View |
IVDR-00807
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HIV Ag/Ab Positive Control
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building Keji 12th Road South Hightech Industrial Park Nanshan 518057 Shenzhen PRC
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China
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06 March 2024
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06 March 2025
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| View |
IVDR-00808
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HBsAg Calibrators
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building Keji 12th Road South Hightech Industrial Park Nanshan 518057 Shenzhen PRC
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China
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06 March 2024
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06 March 2025
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| View |
IVDR-00809
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HBsAg Positive Control
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building Keji 12th Road South Hightech Industrial Park Nanshan 518057 Shenzhen PRC
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China
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06 March 2024
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06 March 2025
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| View |
IVDR-00810
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HBsAg Negative Control
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building Keji 12th Road South Hightech Industrial Park Nanshan 518057 Shenzhen PRC
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China
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06 March 2024
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06 March 2025
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| View |
IVDR-00811
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KINGMED BLOOD COLLECTION VACUUM TUBES SODIUM HEPARIN
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Jiangxi Exqusite Technology Co., Ltd. 1st Road of Yuhu West, Xiaolan Economic Development Zone, Nanchang County, Nanchang City, Jiangxi Province, P.R. China
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China
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18 March 2024
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18 March 2025
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| View |
IVDR-00812
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EDTA K2 GLASS Tubes, 3ml, 13*75mm, Vacuum Bllod Collection Tube For Single-Use
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Suzhou Medmay Biotechnology Co., Ltd. No. 258, Huajin Road, High & New Tech Development Zone, Suzhou, 215153, China Mfd By: Jiangxi Technology Co., Ltd. - 1st Road of Yuhu West, Xiaolan Economic Development Zone, Nanchang County, Nanchang City, Jiangxi Province, P.R. China
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China
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06 March 2024
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06 March 2025
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| View |
IVDR-00813
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HCG Test (Early Pregnany Detection Test) - Cassette
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Pandix Healthcare LLP Office No. 4, First Floor, CSC Pocket E Market, Mayur Vihar Phase-2, Delhi, 110091, India Mfd By: Koshbio Private Limited - Plot No. 39, Blk-1, DLF Industrial Estate, Phase 1, Faridabad Haryana, India
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India
|
07 March 2024
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07 March 2029
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| View |
IVDR-00814
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Rapid Plasma Reagin (RPR) Syphilis Kit
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Fortress Diagnostics Ltd. Unit 2C Antrim Technology Park, Belfast Road, Antrim BT41, 1QS UK
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United Kingdom
|
02 April 2024
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02 April 2029
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| View |
IVDR-00815
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Elecsys Anti-HBc II
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Roche Diagnostics GmbH Sandhofer Strasse 116, 68305 Mannheum, Germany
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Germany
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19 April 2024
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02 April 2025
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| View |
IVDR-00816
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Autobio HIV Ag & Ab Combo CLIA Microparticles Immunoassay
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Autobio Diagnostics Co., Ltd. No. 87 Jingbei Yi Road, National Eco & Tech Development Area, 450016 Zhengzhou, People's Republic of China
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China
|
02 April 2024
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02 April 2029
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| View |
IVDR-00817
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Gloden Vac™ Vacuum Blood Collection Tube-Separate Gel-Clot Activator-PET
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Zhejiang Gongdong Medical Technology Co., LTd. Mo. 10 Beiyuan Ave., Huangyuan 318020 Taizhou, Zhejiang, People's Republic of China
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China
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19 April 2024
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02 April 2025
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| View |
IVDR-00818
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Golden Vac™ Vacuum Blood Collection Tube - EDTA K2-PET
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Zhejiang Gongdong Medical Technology Co., Ltd. No. 10 Beiyuan Ave., Huangyan 318020 Taizhou, Zhejiang, People's Republic of China
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China
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02 April 2024
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02 April 2025
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